Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means the agency’s own highest classification or reported deaths or serious injuries, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

22801–22825 of 40175

ModerateFDA (Devices)·Z-2751-2018·2018-08-22
Terumo CDI System 500 Monitor Recalled for H/Sat Module Self-Test Failure
Terumo is recalling 128 CDI System 500 monitors because a subset of devices fail the automated H/Sat Color Chip Test. This failure disables the H/Sat module but does not cause device inaccuracy.
Product
Monitor with one Blood Parameter Module and one HSat Probe; 500AHCT Monitor with two Blood Parameter modules and one HSat Probe; 500AVHCT Product Usage: The CDI System 500 provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and carbon…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2818-2018·2018-08-22
Arrow Hands-Off Central Venous Catheter Recalled for Packaging Seal Defects
Arrow International Inc. is recalling 7,024 units of Hands-Off Multi-Lumen Central Venous Catheters because packaging may not be sealed, potentially compromising sterility.
Product
HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only with Arrow One-Piece Percutaneous Sheath Introducer System, Material HO-14702 The central venous catheter permits venous access to the central circulation through an indwelling Arrow percutaneous…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2835-2018·2018-08-22
Intuitive Surgical Recalls da Vinci Xi Endoscope Controller for Calibration Defect
Intuitive Surgical is recalling one da Vinci Xi Endoscope Controller due to improper calibration. The defect may cause dim images, color imbalance, or increased fogging.
Product
The da Vinci Xi Surgical System (IS4000) Model Name: IS4000, Endoscope Controller. Model Number: 372601-16.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2750-2018·2018-08-22
Terumo CDI Blood Parameter Monitoring System 500 H/SAT Recalled for Self-Test Failures
Terumo is recalling 128 CDI Blood Parameter Monitoring System 500 H/SAT units because a hybrid intensity shift causes the automated Color Chip Test to fail, disabling the H/Sat module.
Product
CDI Blood parameter monitoring system 500 H/SAT, Part No. 145883 Product Usage: The CDI System 500 provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin and…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2748-2018·2018-08-22
Siemens ARTIS Pheno X-Ray System Recalled for Potential Hardware Thermal Issue
Siemens Medical Solutions USA is recalling 605 ARTIS Pheno interventional fluoroscopic X-ray systems due to a potential hardware issue that may cause thermal effects and damage to system parts.
Product
ARTIS Pheno Model 10849000. Interventional Fluoroscopic X-Ray System Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2742-2018·2018-08-22
Merit Medical Systems Recalls 1mL Medallion Syringes Due to Plunger Defect
Merit Medical Systems is recalling 22,234 units of 1mL Medallion Syringes due to a manufacturing defect in the plunger tip.
Product
1mL Medallion Syringes Are used to inject fluids into, or withdraw fluids from the body.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2836-2018·2018-08-22
DRG Instruments Recalls Salivary Estradiol ELISA Kits Due to Measurement Errors
DRG Instruments GmbH is recalling 169 Salivary Estradiol ELISA kits because poor differentiation between standards may cause lower recovery of estradiol levels.
Product
Salivary Estradiol ELISA, REF SLV-4188 in vitro diagnostic quantitative measurement of active free Estradiol, an estrogenic steroid, in saliva.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2822-2018·2018-08-22
Nico Corp. Recalls Mislabeled Sterile Shepherd's Hook Accessories
Nico Corp. is recalling 204 sterile Shepherd's Hook accessories because they were shipped with incorrect transport labels instead of product labels.
Product
NICO Shepherd' s Hook - Greenberg, sterile. An accessory to NICO s BrainPath device Part Number: NN-8024
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2749-2018·2018-08-22
Richard-Allan Scientific Recalls Mislabeled EZ Single Cytofunnel Brown Units
Richard-Allan Scientific is recalling 1,039 cases of EZ Single Cytofunnel Brown units due to mislabeling. The recall is voluntary and nationwide.
Product
EZ Single Cytofunnel Brown, A78710004 Product Usage: The EZ Single Cytofunnel with Brown filter papter are intended for single use with the Thermo Scientific Cytospin.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2786-2018·2018-08-22
Clarity 10SG Urinalysis Strips Recalled for Analyzer Incompatibility
Clarity Diagnostics is recalling specific lots of Clarity 10SG Urinalysis Strips because they lack a Canister Code Bar Code Label, making them incompatible with Clarity Urocheck 120 Urine Analyzers.
Product
Clarity Urocheck 10SG Urinalysis Strips, Model # DTG-10SG Product Usage: Clarity 10SG Urinalysis Reagent Strips (Urine) are for the qualitative and semi-quantitative detection of the following analytes in urine: Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2827-2018·2018-08-22
Tosoh Bioscience Recalls AIA Analyte Application Manual CDs
Tosoh Bioscience is recalling 9 AIA Analyte Application Manual CDs due to unapproved product labeling. The CDs were distributed to six US states.
Product
Tosoh Bioscience AIA Analyte Application Manual (AAM) CD Part Number: 997027 CD contains analyte application manuals for 47 analyte reagent packs for use with the Tosoh AIA (Automated Immuno-Assay) family of analyzers. Each analyte application manual includes a reference…
Category
Medical Device
Distribution
6 states
SevereFDA (Devices)·Z-2553-2018·2018-08-15
Vyaire Medical Recalls Pediatric AirLife Resuscitation Devices Due to Airflow Obstruction Risk
Vyaire Medical is recalling 15,714 pediatric AirLife Resuscitation Devices because a manufacturing error may obstruct supplemental oxygen airflow during use.
Product
AirLife Resuscitation Device, Pediatric labeled as the following: a. Pediatric, with mask, 28" large bore tubing, pressure-relief valve, Part Number 2K8018; b. Pediatric, with mask, 40" oxygen reservoir bag, pressure-relief valve, Part Number 2K8008; c. Pediatric…
Category
Medical Device
Distribution
28 states
SevereFDA (Devices)·Z-2681-2018·2018-08-15
Howmedica Recalls rHead Stem Implant 6mm Collar Due to Revision Rate
Howmedica Osteonics Corp. is recalling 245 rHead Stem Implant 6mm Collar units because literature reviews indicate a higher revision rate than other similar devices.
Product
rHead Stem Implant 6mm Collar, Size 1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2675-2018·2018-08-15
Howmedica Recalls Stryker Radial Head Implant Assemblies Due to Revision Rate
Howmedica Osteonics Corp. is recalling 191 Stryker rHead Radial Head implant assemblies because literature reviews indicate a higher revision rate than other similar devices.
Product
Lateral Assembly, Radial Head Impl Assembly, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2712-2018·2018-08-15
Howmedica Recalls #3 Bipolar Radial Head Implant Due to Revision Rate
Howmedica Osteonics Corp. is recalling 999 units of the #3 Bipolar radial head implant because literature reviews indicate a higher revision rate than other similar devices.
Product
#3 Bipolar radial head Implant (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2716-2018·2018-08-15
Howmedica Recalls Stryker rHead Radial Head Orthopedic Implants
Howmedica Osteonics Corp. is recalling 543 units of the #2 Bipolar stem implant from the Stryker rHead system due to higher-than-expected revision rates.
Product
#2 Bipolar stem implant (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2736-2018·2018-08-15
FDA Recalls iTOVi Tracker/Scanner Devices Due to Shock Complaints
Hudson Scientific LLC is recalling iTOVi Tracker/Scanner devices because they may not meet manufacturing standards and have caused electric shocks.
Product
iTOVi Tracker/Scanner, Model Nos. ITS10 and ITS15 Intended to rank galvanic skin response measurements. The results are used by the software to generate a report that then makes a recommendation on nutritional supplements.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2660-2018·2018-08-15
Arjohuntleigh Magog Quick Connect 272 KG Scale Recall for Detachment Risk
Arjohuntleigh Magog is recalling Quick Connect 272 KG Scales used with Maxi Sky 2 ceiling lifts because the spreader bar can detach from the scale attachment.
Product
Quick Connect 272 KG Scale used with Maxi Sky 2 ceiling lift The Scale is intended to be used with patient lifters to measure the weight of a patient who cannot stand on a scale. It is designed to be used indoors in hospitals, nursing homes, home care or health care…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2577-2018·2018-08-15
Qiagen AmniSure ROM Test Recalled for Potential Control Line Failure
Qiagen Sciences is recalling 1,620 AmniSure ROM Test kits because the control line may not appear on the test strip, potentially affecting result validity.
Product
AmniSure ROM Test under the following labels: 1) Catalog Number FMRT-1-25 and 2) Catalog Number FMRT-1-25-CA Product Usage: Rapid, non-instrumented, qualitative immunochromatographic test for the in vitro detection of amniotic fluid in vaginal discharge of pregnant women.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2686-2018·2018-08-15
Howmedica Recalls rHead Recon Stem Implant Due to Higher Revision Rates
Howmedica Osteonics Corp. is recalling 303 rHead Recon Stem Implant Plasma Coated, Size 2 units because literature reviews indicate a higher revision rate than other similar devices.
Product
rHead Recon Stem Implant Plasma Coated, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2685-2018·2018-08-15
Howmedica Recalls rHead Recon Stem Implants Due to Revision Rate Concerns
Howmedica Osteonics Corp. is recalling 314 rHead Recon Stem Implants because literature reviews indicate a higher revision rate than other similar devices.
Product
rHead Recon Stem Implant Plasma Coated, Size 1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2738-2018·2018-08-15
Datex-Ohmeda Neonatal Flow Sensor Cable Recall for Missing Connector Housing
Datex-Ohmeda is recalling 417 Neonatal Flow Sensor Cables because the connector housing may be missing, exposing internal wires. The defect poses a risk of electrical shock or fire.
Product
The Neonatal Flow Sensor Cable used on devices CARESCAPE R860, ENGSTROM CARESTATION, ENGSTROM PRO and contained in Neonatal Software Upgrade Kit 2080496-010. The CARESCAPE R860 ventilator is designed to provide mechanical ventilation or support to neonatal, pediatric, and…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2552-2018·2018-08-15
Vyaire Medical Recalls AirLife Adult Resuscitation Devices Due to Airflow Obstruction
Vyaire Medical is recalling 15,714 AirLife Adult Resuscitation Devices because a manufacturing error may obstruct supplemental oxygen airflow during use.
Product
AirLife Resuscitation Device, Adult labeled as the following: a. Adult, with mask, oxygen reservoir bag, Part Number 2K8004; b. Adult, with mask, oxygen reservoir bag, CO2 detector, PEEP valve, Part Number 2K8035C2; c. Adult, with mask, 28" large bore tubing, Part…
Category
Medical Device
Distribution
28 states
SevereFDA (Devices)·Z-2734-2018·2018-08-15
Waterpik Sonic-Fusion Professional Recall Due to Charging Base Overheating
Water Pik, Inc. is recalling 3,797 Waterpik Sonic-Fusion Professional units because the charging base may overheat, melt, or spark, posing fire, shock, or burn risks.
Product
Waterpik Sonic-Fusion Professional, Model: SF-02 Product Usage: The device is composed of a unit base and an oral irrigator/ battery operated brush power handle. The device provides a pulsating stream of potable water and/or powered toothbrush action to remove plaque and…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2690-2018·2018-08-15
Howmedica Recalls rHead Recon Stem Implants Due to Higher Revision Rates
Howmedica Osteonics Corp. is recalling 269 rHead Recon Stem Implants because literature reviews indicate a higher revision rate than other similar devices.
Product
rHead Recon Stem Implant 6mm Collar, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide

How to read this listing

Filters

22801–22825 of 40175